Dr Paul Schaffer, Nuclear-Medicine Division, TRIUMF & Dr François Bénard, Scientific Director, University of BC.

Isotopes: Made-in-Canada solutions, not shortages

By Dr Paul Schaffer and Dr François Bénard

A recent article by Kelly Crowe ("The made-in-Canada isotope shortage facing medical scans", CBC News May 26, 2014) articulates just how tough change can be, especially for our healthcare system. In response to medical-isotope supply issues, the federal government decided to diversify Canada's supply chain. This involved an unappealing, yet tantalizing idea of permanently ceasing medical isotope production at the world's largest isotope production facility — the NRU nuclear reactor, operated by Atomic Energy of Canada Ltd (AECL) at Chalk River ON.

The isotope in the spotlight is molybdenum-99, proud parent isotope of technetium-99m (Tc-99m), the world's most widely-used medical isotope. Canada is a major driver of the Tc-99m global supply chain. The government's intention was to shift how Canada produces medical isotopes, which is currently based on the fission of enriched uranium.

The NRU is old — 57 years old to be precise — and building a new reactor would exceed $1 billion in taxpayer dollars. When coupled to additional expenses of removing, storing and transporting spent nuclear material back to the United States, one can see why a change should be considered.

Consider also that Canada has no means to package the medical isotopes in the form used by hospitals, weekly shipments of isotopes are sent out of Canada, repackaged in other countries, and then sold back to our provincial healthcare providers at a premium. Since the NRU reactor produces many more isotopes than are required in Canada, the majority of its products are sold internationally. This creates a situation in which Canadian tax dollars subsidize the medical isotopes used in the healthcare of others abroad.

AECL achievements

Make no mistake, we should be deeply proud of what AECL has accomplished, as well as what it represents — Canadian excellence. Canada is and remains a leader in the field of nuclear science for peaceful purposes. Those individuals involved with the development, installation and operation of the NRU and numerous CANDU reactors around the globe embody Canadian excellence, and it is to them we owe our reputation for innovation.

But nuclear innovation still courses through our collective blood. In 2009, after a leak caused a prolonged shutdown of the NRU reactor, we (a team led by TRIUMF with members from the BC Cancer Agency, Centre for Probe Development & Commercialization, and Lawson Health Research Institute) decided to revisit the concept of producing Tc-99m using medical cyclotrons.

Cyclotrons are particle accelerators that rely on electricity and magnets to create isotopes by accelerating ions and bombarding non-radioactive materials. The result is medical isotopes produced without a reactor, without enriched uranium, and without long-lived radioactive waste.

Comprehensive solution

By taking a concept proposed in 1971 by researchers at the University of Miami (Beaver and Hupf), we developed a comprehensive solution to produce very large quantities of Tc-99m using cyclotrons. This work was funded by the Natural Sciences and Engineering Research Council, the Canadian Institutes of Health Research, and subsequently Natural Resources Canada.

Our process is suitable for large population bases, using medical cyclotrons already installed and operational in our major hospitals throughout the country. We have demonstrated that cyclotrons in Vancouver, London, and Hamilton have sufficient capacity to supply their respective hospital catchments with Tc-99m.

Incorporate this technology into more of the 20 cyclotrons in operation in Canada today and you have a sizeable capacity to produce Tc-99m without using reactors. The technology is now ready for clinical testing and we are moving forward to obtain regulatory approval for routine use in patients with a target date of 2016. Other teams in Canada are pursuing similar projects, demonstrating Canadian innovation. The world is looking to us to lead the way.

Even so, more cyclotrons would be needed to completely cover Canadian needs, but they are relatively inexpensive when compared to a reactor. Turn-key installation costs for a brand-new modern cyclotron facility come in at $10-15 million each. A cross-Canada network of Tc99m-producing cyclotrons can thus be developed at a more reasonable cost than funding or replacing a reactor.

The beauty of cyclotrons is that they have long been making other short-lived medical isotopes, supporting a paradigm that would see a decentralized medical isotope production model that can produce a complement of isotopes for future healthcare needs. Added benefit is that Canada is home to two manufacturers of cyclotrons.

The need for change

Do we need change? Should Canada continue to provide the most popular isotope, Tc-99m, to the world at its own expense?

The long-term, high-scale subsidies of research reactors that exist throughout the world has created a stagnant, complacent market and stifled innovation. While radioisotope prices have remained low, these costs will escalate as reactors age and are repaired or replaced.

Additional headwinds persist with new US government mandates that seek to reduce the global stockpile of highly enriched uranium. Member countries of the Organization for Economic Co-operation and Development have agreed to require full cost recovery in order to properly account for the price of radioisotopes.

Cyclotron-produced Tc-99m is no-longer a research exercise, but a true innovative reality that will be in place by 2016. Let us continue to demonstrate our leadership in nuclear science by showing the world that medical isotopes such as Tc-99m can be produced without reactors, without enriched uranium, and without long-lived radioactive waste.

Dr Paul Schaffer is head of the Nuclear-Medicine Division at TRIUMF. Dr François Bénard is the Scientific Director of the Centre of Excellence for Functional Cancer Imaging at the BC Cancer Research Agency, University of British Columbia.

Note: Kelly Crowe's article can be found at: www.cbc.ca/news/health/the-made-in-canada-isotope-shortage-facing-medical-scans-1.2652667.